It is known that food may decrease the extent and or delay of the absorption of pharmaceutical agents, as shown by lower peak concentration and lower AUC in plasma and a prolongation of time to peak plasma concentration following administration of a single immediate release tablet a pharmaceutical agent with food, compared to the same tablet strength administered without food. Very often these pharmaceutical agents are marketed as immediate release formulation and have to be administered several times a day a situation that has raised concerns regarding patient compliance. There are also pharmaceutical agents that can't be taken with food because food may decreases their bioavailability.
Limited research work has been done to address these problems and no successful work has been reported on an extended release pharmaceutical composition or dosage form-that when taken with meals does not result in a decrease in bioavailability.
Current drug delivery techniques such as matrix tablets, osmotic tablets and delayed release tablets are not suitable because the extent of drug release or bioavailability is not optimal or does not provide sufficient coverage over a 12 hours and 24 hours period when taken with food. Furthermore, for coated tablets the choice of coating polymer(s) makes large scale or commercial production of consistent and reproducible batches difficult if not impossible. The manufacturing process for these formulations involves long process times and large number of process steps, requiring qualification, cleaning and validation. Stability problems during manufacture and storage may be an issue with current controlled systems especially for the delivery of large doses.